BEUDAMED
    FDA Adverse Event Death Summary report: N

    HOMECHOICE

    MDR report key: 2003334 · Received March 1, 2011

    Report

    Report Number
    1423500-2011-02572
    Event Type
    Death
    Date Received
    March 1, 2011
    Date of Event
    January 17, 2011
    Report Date
    January 17, 2011
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K053512
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, AND/OR UPON CONCLUSION OF BAXTER'S INVESTIGATION, A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION OBTAINED ON (B)(6) 2011 HAS BEEN ENTERED UPON FURTHER REVIEW OF THE EVENT DETAILS, BAXTER HAS DETERMINED THAT THE RETURNED INSTRUMENT TEST EVALUATION (RITE) TEST FAILURE FOR VOLUMETRIC ACCURACY IS NOT ASSOCIATED WITH THIS REPORTED PATIENT DEATH.

    Description of Event or Problem · 1

    THE FOLLOWING ADDITIONAL INFORMATION WAS OBTAINED FROM THE PATIENT'S PD NURSE ON (B)(6) 2011: THE PATIENT WAS NOT CONNECTED TO THE HOMECHOICE (HC) DEVICE AT THE TIME OF DEATH. THE NURSE INDICATED THE PATIENT DID NOT HAVE ANY PROBLEMS WITH THE HC DEVICE PRIOR TO HIS DEATH. THE NURSE INDICATED SHE DID NOT HAVE ANY ADDITIONAL INFORMATION TO PROVIDE.

    Description of Event or Problem · 1

    THE CUSTOMER DISCONTINUED USE OF THE HOMECHOICE (HC) MACHINE AND RETURNED IT TO BAXTER (B)(4). THE BAXTER PRODUCT ANALYSIS LABORATORY (PAL) REPORTED THAT THE HC MACHINE FAILED RITE (RETURNED INSTRUMENT TEST EVALUATION) DUE TO THERAPY MONITORED VOLUME FAILED PERFORMANCE SPEC, FILL 1, 822.6ML. FILL 2, 821.6ML. IT WAS IDENTIFIED THAT THE HOMECHOICE DEVICE WAS RETURNED AS THE HOME PATIENT (HP) PASSED AWAY ON (B)(6) 2010 DUE CARDIAC ARREST/FAILURE. IT WAS NOT REPORTED WHETHER AN AUTOPSY WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOMECHOICE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Death